BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 9140949 · Received October 1, 2019

    Report

    Report Number
    2015691-2019-03638
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    THE DELIVERY SYSTEM WAS RETURNED TO EDWARDS LIFESCIENCES FOR EVALUATION AFTER BEING USED IN THE PROCEDURE. UPON INFLATING AND DEFLATING THE BALLOON, A PIN HOLE WAS DISCOVERED ON THE DISTAL END OF THE INFLATION BALLOON NEAR THE BALLOON TAPER. NO OTHER ABNORMALITIES WERE NOTED. DIMENSIONAL TESTING WAS PERFORMED ON THE DOUBLE WALL THICKNESS AND ALL MEASUREMENTS MET SPECIFICATION. DURING MANUFACTURING, THE DELIVERY SYSTEM IS BOTH VISUALLY INSPECTED AND TESTED SEVERAL TIMES THROUGHOUT THE PROCESS. ALL INSPECTIONS ARE CONDUCTED ON 100% OF UNITS, EXCEPT IN THE CASE OF PRODUCT VERIFICATION (PV) TESTING, WHERE THE TESTED UNITS ARE CHOSEN ON A SAMPLING BASIS. THESE INSPECTIONS DURING MANUFACTURING AND TESTING DURING PV SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED COMPLAINT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND REVEALED NO MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A LOT HISTORY REVIEW WAS PERFORMED AND REVEALED NO ADDITIONAL SIMILAR COMPLAINTS. A REVIEW OF THE COMPLAINT HISTORY FROM OCTOBER 2018 THROUGH SEPTEMBER 2019 REVEALED OTHER RETURNED SIMILAR COMPLAINTS; HOWEVER, NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THESE EVALUATIONS. AVAILABLE INFORMATION SUGGESTED THAT PATIENT AND OR PROCEDURAL FACTORS MAY HAVE CAUSED OR CONTRIBUTED TO THE SIMILAR EVENTS. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THE OCCURRENCE RATE DID NOT EXCEED THE CONTROL LIMIT FOR THE TREND CATEGORIES. A REVIEW OF THE INSTRUCTION FOR USE (IFU) AND TRAINING MANUALS FOR REVEALED NO DEFICIENCIES. PER THE IFU: IF DELIVERY SYSTEM BALLOON RUPTURES OR LEAKS DURING DEPLOYMENT WITHOUT THV EMBOLIZATION: DO NOT USE EXCESSIVE FORCE. TAKE CARE WHEN CROSSING THE THV, TRACKING BACK OVER THE ARCH AND REMOVING THE DELIVERY SYSTEM (THROUGH THE TIP OF THE SHEATH); MAINTAIN GUIDEWIRE POSITION; CHECK FOR PV LEAKS UNDER ECHO; IF POST-DILATION NEEDED, USE A NEW DELIVERY SYSTEM. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINT FOR BALLOON LEAKAGE WAS CONFIRMED BASED ON VISUAL INSPECTION/FUNCTIONAL TESTING. HOWEVER, A MANUFACTURING NON-CONFORMANCE COULD NOT BE IDENTIFIED. A REVIEW OF THE MANUFACTURING MITIGATIONS IN PLACE SUPPORTS THAT THE DELIVERY SYSTEM HAS PROPER INSPECTIONS IN PLACE TO DETECT ISSUES RELATED TO THE REPORTED EVENT. BASED ON THE COMPLAINT HISTORY REVIEW, DHR AND LOT HISTORY THERE IS NO EVIDENCE TO CONFIRM A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE COMPLAINT. WHILE NO PATIENT INFORMATION WAS PROVIDED, COMPLAINT HISTORY SUGGESTS THAT PATIENT FACTORS SUCH AS CALCIFICATION MAY HAVE CONTRIBUTED TO THE OBSERVED DEVICE DAMAGE. CALCIUM PRESENT IN THE ACCESS VESSEL CAN INTERACT WITH THE INFLATION BALLOON AND CAUSE DAMAGE SUCH AS PIN HOLES. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. HOWEVER, WITHOUT FURTHER INFORMATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED. SINCE NO PRODUCT NON-CONFORMANCE WAS CONFIRMED AND THE OCCURRENCE RATE DID NOT EXCEED THE COMPLAINT CONTROL LIMITS, A CORRECTIVE/PREVENTATIVE ACTIONS AND A PRODUCT RISK ASSESSMENT (PRA) ARE NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TRANSFEMORAL TAVR WITH A 23MM ULTRA S3 VALVE WITH THE COMMANDER DELIVERY SYSTEM AND ESHEATH, THE DELIVERY SYSTEM BALLOON LEAKAGE WAS NOTED. UPON INFLATING THE BALLOON, THE VALVE DID NOT FULLY EXPAND, AND ON RETRACTION, BLOOD WAS SEEN IN THE ATRION. THE DELIVERY SYSTEM WAS REMOVED WITH NO INJURY TO THE PATIENT. A NEW SYSTEM WAS PREPPED AND THE VALVE WAS IMPLANTED SUCCESSFULLY. THE PATIENT IS STABLE POST PROCEDURE. UPON INSPECTION OF THE DELIVERY SYSTEM ON THE BACK TABLE, 2 PINHOLES WERE NOTED ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937212 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600LDS23A 62372194

    Patients

    Seq Age Sex Outcome Treatment
    1